Website:
tacticityadvisors.com
Job details:
This is a senior individual-contributor role. You would own regulatory engagements from the first client conversation through to filing working out the pathway, planning the evidence, writing the submission, and handling the correspondence when FDA comes back with questions.
Tacticity is a small practice, so the work is hands-on. There is no layer between you and the client, and no team of juniors to hand the drafting to. What you get in return is range in a single quarter you might work on a Class II implant, an IVD and a piece of software-as-a-medical-device. You would also be the person a client calls when something goes sideways: an AI request nobody expected, or a predicate that stops working halfway through.
You would work closely with the founder, who spent his career reviewing these submissions from the other side of the desk at FDA. Expect your reasoning to be questioned, and expect to question back.
What You Would Be Doing• Own the regulatory strategy on your engagements,classification and predicate analysis, pathway determination, and the evidence plan to support it.
• Lead 510(k), De Novo, PMA and Q-Submission preparation end to end, from outline to filing.
• Draft responses to Additional Information requests and deficiency letters, and help clients decide what to concede, what to argue, and what to test again.
• Run client meetings directly, including the difficult ones where the answer is not what the client wants to hear.
• Review test reports, biocompatibility evaluations and chemical characterisation data, and work out whether they actually support the claim being made.
• Review the work of Regulatory Affairs Associates, and contribute to scoping and proposals for new engagements.
What We Are Looking For• Three to five or more years of hands-on regulatory affairs experience in medical devices, IVDs or SaMD. Consulting, CRO and in-house manufacturer backgrounds are all welcome.
• At least one FDA submission you personally drafted a substantial part of, from a blank page through to filing. We will ask you about it in detail, what the pathway was, what you argued, and what FDA came back with.
• A Bachelor's, Master's, PharmD, MTech or PhD in Life Sciences, Biomedical Engineering, Biotechnology, Pharmacy, Engineering or a related field.
• Working knowledge of 21 CFR Parts 807, 814 and 820, ISO 13485, ISO 10993, and IEC 62304 where software is involved.
• Writing a reviewer can follow without effort, a submission is an argument, and a badly written one loses.
• The judgement to say when a question is outside your experience rather than guessing. A confident wrong answer is expensive in this work.
Useful, But Not EssentialDirect correspondence with FDA reviewers; work on AI or machine-learning enabled devices or combination products; exposure to EU MDR alongside FDA; or experience of a submission that did not go well, and a clear view of why.
What This Role Is NotWorth being straightforward, because the fit matters more than the CV. This is not a large-company role with a narrow scope, you may be doing strategy in the morning and formatting a submission table in the afternoon. It is not a quality or QMS role. And it is not, at least initially, a people-management role: you would mentor associates, but not have a team reporting to you from day one.
Location & CompensationThis position is hybrid (office location – Baner) and may be structured as either full-time or part-time depending on the candidate.
Compensation will be commensurate with experience, qualifications, and level of engagement.
How to ApplyInterested candidates should email their resume/CV to:
contact@tacticityadvisors.com
Subject line: Application – Regulatory Affairs Manager / Consultant
In the body of the email, please summarise your relevant experience and the device categories you have worked on; describe one submission you worked on, setting out the regulatory question, what you decided and what you would do differently now; and say briefly why this role interests you.
Written communication is central to this role, so the application email itself forms part of the assessment. We would rather read three thoughtful paragraphs than a polished cover letter that could have been sent to anyone.
Click on Apply to know more.
